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Re: cowtown jay post# 41279

Tuesday, 12/26/2023 11:34:15 AM

Tuesday, December 26, 2023 11:34:15 AM

Post# of 44352
Do we potentially have a case against the FDA for failing to fast track us as it approves other drugs with questionable success rates?
https://www.biospace.com/article/6-drugs-approved-despite-failed-trials-or-minimal-data-/?s=74

I believe Vanda currently has an open case against the FDA for a denial of fast track. In my opinion failure to pass judgement is non-approval when you have satisfied what is required for consideration.

https://www.bloomberglaw.com/public/desktop/document/VANDAPHARMACEUTICALSINCvFOODANDDRUGADMINISTRATIONetalDocketNo122c?doc_id=X26T5V243949RK895SH4KFQU9TC

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